FDA Dings Novartis for Facebook Widget

By Katherine Hobson

College kids worry (or should) that photos of their most awesome keg-stand moments will be found by prospective employers. Drug makers have different concerns about Facebook and other social media — namely, how to promote their products within both the confines of limited space (like a 140-character Tweet) and the FDA’s marketing regulations.

In a faxed letter posted this week to the agency’s website, the FDA told Novartis that the information generated by the “Facebook Share” widget on the drug maker’s website for Tasigna (approved to treat a type of leukemia) runs afoul of FDA regs about disclosure and permitted claims in marketing materials. Clicking on the widget will send Novartis-authored information about the drug to a user’s Facebook page.

“The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug,” says the letter from Karen Rulli, acting group leader of the division of drug marketing, advertising, and communications. “In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products.” It’s the first time the FDA has issued an enforcement letter over a Facebook widget, an FDA spokeswoman says.

A Novartis spokeswoman said, via email, that the company “takes the letter issued by the FDA very seriously and we have addressed its concerns by taking the direct and immediate action of taking down the widget referenced by the FDA.” The company will go over all its online materials in light of the FDA’s concerns, she wrote.

Back in November the FDA held public hearings to get input on how drugs and medical devices should be promoted online and through social media. Its guidance isn’t out yet.

In a regulatory alert posted to its website, health-care marketing agency Digitas Health writes that this enforcement action “does NOT answer all of the questions raised during the social media hearings or about the use of social media in general” but does “clarify some issues.”

Based on the letter, one takeaway is that “the lessons of this enforcement action apply to all social media, not just Facebook,” the alert says. It notes that the FDA singled out Novartis-generated content for its ire, which seems to suggest that user-generated comments — say, if the Facebook sharer appended “This saved my mom’s life with no side effects” to the official info — aren’t going to be the responsibility of drug companies.

Comments (5 of 6)

Sounds a lot like the 14 DDMAC letters sent out in November 2009 on the general topic of sponsored Google links. The key take-away from those letters wasn’t that the agency was condemning the use of social media – but that “sponsored” = “advertising.” Sound logic.

Is a company-sponsored product-specific FaceBook widget advertising? Of course.

The Tasigna letter should not be taken as a signal that the agency is restricting use of social media – it’s a signal that the rules (which, in this case are pretty clear) should be followed. But, no doubt, those rules need to be clarified.

On a more peculiar note (and according to a report in the Pink Sheet), “The agency said DDMAC is not working on draft guidance for issues related to Internet adverse event reporting because it is outside its purview.”

That is surprising and disappointing – and requires further thought from the folks at White Oak.

10:32 am August 8, 2010

Internist wrote :

Interesting thread.

For the life of me, and for protecting the lives of my patients, I do not see how Novartis gets dinged for this while patients are dying and bleeding and stroking and falling, having been neglected and mistreated at the hands of electronic medical devices passed off as EHRs and CPOEs which have NOT undergone any assessment for safety and efficacy and usability. Hello?

12:22 pm August 7, 2010

General Surgeon wrote :

Pharma is being screwed by the FDA whereas the producers of CPOE equipment (equipment that only serves to slow down processes in the hospital and cause delays and errors with post op patients) have goyten a free pass.

More patients have died from defective HIT devices that are not regulated than from Novartis not listing the side effects of its medications.

What are the side effects of EMRs and CPOEs that break down unexpectedly and facilitate mistakes of innumerable types.

Editor Comment

11:51 am August 7, 2010

Katherine Hobson wrote :

I fixed the link. Thank you, Dale.

10:44 pm August 6, 2010

This blog is not working_Doctor Zhivago wrote :

Did not list the risks? Just like the electronic medical record vendors and makers who not only do not list the risks, but do not even have their devices approved!

Why are the applicable laws of the F D and C Act being applied to pharma and certain medical device makers but not to the manufacturers of electronic records and medication ordering devices?